U.S. patent application number 17/542096 was filed with the patent office on 2022-06-09 for passive dilation in catheter insertion systems.
The applicant listed for this patent is Bard Access Systems, Inc.. Invention is credited to Daniel B. Blanchard, Austin J. Mckinnon, Joe Spataro, Kyle G. Thornley.
Application Number | 20220176081 17/542096 |
Document ID | / |
Family ID | |
Filed Date | 2022-06-09 |
United States Patent
Application |
20220176081 |
Kind Code |
A1 |
Spataro; Joe ; et
al. |
June 9, 2022 |
Passive Dilation in Catheter Insertion Systems
Abstract
Disclosed herein is a catheter, which in some embodiments
includes a distal section configured to enter a skin insertion
site. The distal section can include a tapered junction having one
or more dilation structures configured to dilate the skin insertion
site. The distal section can further include a distal portion
extending from a distal end of the tapered junction, the distal
portion having a diameter smaller than a proximal portion of the
catheter. In combination, the tapered junction, the one or more
dilation structures, and the specific actions of the user urging
the catheter into the insertion site can result in an improved fit
of the catheter in the insertion site.
Inventors: |
Spataro; Joe; (Cottonwood
Heights, UT) ; Blanchard; Daniel B.; (Bountiful,
UT) ; Thornley; Kyle G.; (Farmington, UT) ;
Mckinnon; Austin J.; (Herriman, UT) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Bard Access Systems, Inc. |
Salt Lake City |
UT |
US |
|
|
Appl. No.: |
17/542096 |
Filed: |
December 3, 2021 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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63121761 |
Dec 4, 2020 |
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International
Class: |
A61M 25/06 20060101
A61M025/06 |
Claims
1. A distal section of a catheter configured to enter a skin
insertion site, comprising: a tapered junction including one or
more dilation structures configured to dilate the skin insertion
site; and a distal portion extending from a distal end of the
tapered junction, the distal portion having a diameter smaller than
a proximal portion of the catheter.
2. The distal section of the catheter according to claim 1, wherein
the one or more dilation structures includes one or more
protrusions or a helix extending from a side wall of the tapered
junction.
3. The distal section of the catheter according to claim 2, wherein
the one or more dilation structures extend radially from the side
wall of the tapered junction.
4. The distal section of the catheter according to claim 2, wherein
each protrusion includes a proximal edge and a distal edge.
5. The distal section of the catheter according to claim 4, wherein
each protrusion extends longitudinally from the proximal edge to
the distal edge.
6. The distal section of the catheter according to claim 5, wherein
each protrusion extends laterally from the side wall to an
apex.
7. The distal section of the catheter according to claim 6, wherein
the apex is located between a longitudinal mid-point and one of the
proximal edge or the distal edge, including the proximal edge or
the distal edge.
8. The distal section of the catheter according to claim 7, wherein
each protrusion defines a proximal face extending between the apex
and the proximal edge.
9. The distal section of the catheter according to claim 7, wherein
each protrusion defines a distal face extending between the apex
and the distal edge.
10. The distal section of the catheter according to claim 8,
wherein the proximal face defines a cutting edge extending
longitudinally through a midline of the proximal face.
11. The distal section of the catheter according to claim 9,
wherein the distal face defines a cutting edge extending
longitudinally through a midline of the distal face.
12. The distal section of the catheter according to claim 2,
wherein the protrusions are longitudinally organized into a first
line of two or more protrusions and a second line of two or more
protrusions disposed on opposite sides of the tapered junction.
13. The distal section of the catheter according to claim 2,
wherein the proximal face and the distal face of each of the
protrusions coordinate to define a rounded outer profile.
14. The distal section of the catheter according to claim 12,
wherein each of the protrusions of the first line is longitudinally
aligned with each of the protrusions of the second line.
15. The distal section of the catheter according to claim 12,
wherein each of the protrusions of the first line is longitudinally
offset from each of the protrusions of the second line.
16. The distal section of the catheter according to claim 2,
wherein the helix includes a right handed helix or a left handed
helix.
17. The distal section of the catheter according to claim 2,
wherein the helix includes beveled or chamfered edges.
18-29. (canceled)
Description
PRIORITY
[0001] This application claims the benefit of priority to U.S.
Provisional Application No. 63/121,761, filed Dec. 4, 2020, which
is incorporated by reference in its entirety into this
application.
BACKGROUND
[0002] In some catheter placement procedures, dilation of the
tissue surrounding an insertion site is a core activity that occurs
during catheter placement. Proper dilation of the tissue allows an
improved fit of the catheter. Current dilation techniques are done
by hand, using a separate hardened component and/or a skin nick to
relieve the tension in the skin while dilating the tissue. These
techniques require the insertion and removal of various instruments
adding complexity, time and increasing the risk of infection.
Furthermore, these techniques may lead to undesired tissue
deflection and require increased pushing forces resulting in over
dilation of the tissue surrounding the insertion site. It would be
beneficial to be able to dilate only the tissue necessary for the
fit of the catheter and reduce the necessity of the skin nick.
Disclosed herein is a system and method of use that address the
foregoing.
SUMMARY
[0003] Disclosed herein is a distal section of a catheter
configured to enter a skin insertion site including a tapered
junction including one or more dilation structures configured to
dilate the skin insertion site, and a distal portion extending from
a distal end of the tapered junction, the distal portion having a
diameter smaller than a proximal portion of the catheter.
[0004] In some embodiments, the one or more dilation structures
includes one or more protrusions or a helix extending from a side
wall of the tapered junction.
[0005] In some embodiments, the one or more dilation structures
extend radially from the side wall of the tapered junction.
[0006] In some embodiments, each protrusion includes a proximal
edge and a distal edge.
[0007] In some embodiments, each protrusion extends longitudinally
from the proximal edge to the distal edge.
[0008] In some embodiments, each protrusion extends laterally from
the side wall to an apex.
[0009] In some embodiments, the apex is located between a
longitudinal mid-point and one of the proximal edge or the distal
edge, including the proximal edge or the distal edge.
[0010] In some embodiments, each protrusion defines a proximal face
extending between the apex and the proximal edge.
[0011] In some embodiments, each protrusion defines a distal face
extending between the apex and the distal edge.
[0012] In some embodiments, the proximal face defines a cutting
edge extending longitudinally through a midline of the proximal
face.
[0013] In some embodiments, the distal face defines a cutting edge
extending longitudinally through a midline of the distal face.
[0014] In some embodiments, the protrusions are longitudinally
organized into a first line of two or more protrusions and a second
line of two or more protrusions disposed on opposite sides of the
tapered junction.
[0015] In some embodiments, the proximal face and the distal face
of each protrusion coordinate to define a rounded outer
profile.
[0016] In some embodiments, each protrusion of the first line is
longitudinally aligned with each protrusion of the second line.
[0017] In some embodiments, each protrusion of the first line is
longitudinally offset from each protrusion of the second line.
[0018] In some embodiments, the helix includes a right handed helix
or a left handed helix.
[0019] In some embodiments, the helix includes beveled or chamfered
edges.
[0020] Also disclosed herein is a method of inserting a catheter
including inserting a distal section of a catheter into a skin
insertion site, the distal section having a tapered junction
including one or more dilation structures configured to dilate the
skin insertion site and a distal portion extending from a distal
end of the tapered junction, the distal portion having a diameter
smaller than a proximal portion of the catheter, dilating the skin
insertion site, and advancing the proximal portion of the catheter
into the skin insertion site.
[0021] In some embodiments, the one or more dilation structures
include one or more protrusions or a helix extending from a side
wall of the tapered junction.
[0022] In some embodiments, each protrusion includes a proximal
face and a distal face.
[0023] In some embodiments, the proximal face defines a cutting
edge extending longitudinally through a midline of the proximal
face.
[0024] In some embodiments, the distal face defines a cutting edge
extending longitudinally through a midline of the distal face.
[0025] In some embodiments, dilating the skin insertion site
includes using the cutting edge to dilate the insertion site.
[0026] In some embodiments, dilating the skin insertion site
includes rotating a helical dilation structure about a longitudinal
axis to dilate the insertion site.
[0027] In some embodiments, wherein the helix includes a right
handed helix or left handed helix.
[0028] In some embodiments, the helix includes beveled or chamfered
edges.
[0029] In some embodiments, dilating the skin insertion site
includes using the beveled or chamfered edges to dilate the
insertion site.
[0030] In some embodiments, dilating the skin insertion site
includes twisting the distal section of the catheter around a
longitudinal axis, clockwise or counterclockwise.
[0031] In some embodiments, dilating the skin insertion site
includes wiggling the distal section of the catheter about a
transverse or lateral axis.
[0032] These and other features of the concepts provided herein
will become more apparent to those of skill in the art in view of
the accompanying drawings and following description, which describe
particular embodiments of such concepts in greater detail.
DRAWINGS
[0033] A more particular description of the present disclosure will
be rendered by reference to specific embodiments thereof that are
illustrated in the appended drawings. It is appreciated that these
drawings depict only typical embodiments of the invention and are
therefore not to be considered limiting of its scope. Example
embodiments of the invention will be described and explained with
additional specificity and detail through the use of the
accompanying drawings in which:
[0034] FIG. 1 illustrates a plan view of a catheter insertion
system, in accordance with some embodiments.
[0035] FIG. 2 illustrates a perspective view of components of a
catheter insertion system including a tapered junction, in
accordance with some embodiments.
[0036] FIG. 3A illustrates a schematic view of an exemplary
dilation structure, in accordance with some embodiments.
[0037] FIGS. 3B-3I illustrates perspective views of various
embodiments of the one or more dilation structures, in accordance
with some embodiments.
[0038] FIGS. 4A-4D illustrate cross sectional views of various
embodiments of the dilation structures, in accordance with some
embodiments.
[0039] FIGS. 5A-5C illustrate an exemplary method of inserting a
catheter into an insertion site, in accordance with some
embodiments.
[0040] FIG. 6 illustrates a flow chart of an exemplary method of
inserting a catheter, in accordance with some embodiments.
DESCRIPTION
[0041] Before some particular embodiments are disclosed in greater
detail, it should be understood that the particular embodiments
disclosed herein do not limit the scope of the concepts provided
herein. It should also be understood that a particular embodiment
disclosed herein can have features that can be readily separated
from the particular embodiment and optionally combined with or
substituted for features of any of a number of other embodiments
disclosed herein.
[0042] Regarding terms used herein, it should also be understood
the terms are for the purpose of describing some particular
embodiments, and the terms do not limit the scope of the concepts
provided herein. Ordinal numbers (e.g., first, second, third, etc.)
are generally used to distinguish or identify different features or
steps in a group of features or steps, and do not supply a serial
or numerical limitation. For example, "first," "second," and
"third" features or steps need not necessarily appear in that
order, and the particular embodiments including such features or
steps need not necessarily be limited to the three features or
steps. Labels such as "left," "right," "top," "bottom," "front,"
"back," and the like are used for convenience and are not intended
to imply, for example, any particular fixed location, orientation,
or direction. Instead, such labels are used to reflect, for
example, relative location, orientation, or directions. Singular
forms of "a," "an," and "the" include plural references unless the
context clearly dictates otherwise.
[0043] With respect to "proximal," a "proximal portion" or a
"proximal-end portion" of, for example, a catheter disclosed herein
includes a portion of the catheter intended to be near a clinician
when the catheter is used on a patient. Likewise, a "proximal
length" of, for example, the catheter includes a length of the
catheter intended to be near the clinician when the catheter is
used on the patient. A "proximal end" of, for example, the catheter
includes an end of the catheter intended to be near the clinician
when the catheter is used on the patient. The proximal portion, the
proximal-end portion, or the proximal length of the catheter can
include the proximal end of the catheter; however, the proximal
portion, the proximal-end portion, or the proximal length of the
catheter need not include the proximal end of the catheter. That
is, unless context suggests otherwise, the proximal portion, the
proximal-end portion, or the proximal length of the catheter is not
a terminal portion or terminal length of the catheter.
[0044] With respect to "distal," a "distal portion" or a
"distal-end portion" of, for example, a catheter disclosed herein
includes a portion of the catheter intended to be near or in a
patient when the catheter is used on the patient. Likewise, a
"distal length" of, for example, the catheter includes a length of
the catheter intended to be near or in the patient when the
catheter is used on the patient. A "distal end" of, for example,
the catheter includes an end of the catheter intended to be near or
in the patient when the catheter is used on the patient. The distal
portion, the distal-end portion, or the distal length of the
catheter can include the distal end of the catheter; however, the
distal portion, the distal-end portion, or the distal length of the
catheter need not include the distal end of the catheter. That is,
unless context suggests otherwise, the distal portion, the
distal-end portion, or the distal length of the catheter is not a
terminal portion or terminal length of the catheter.
[0045] Unless defined otherwise, all technical and scientific terms
used herein have the same meaning as commonly understood by those
of ordinary skill in the art.
[0046] FIG. 1 illustrates a plan view of a catheter insertion
system 100, in accordance with some embodiments. In some
embodiments, the catheter insertion system 100 includes a catheter
110 having a hub 112 disposed at a proximal end and including one
or more extension legs extending proximally from the proximal end
of the hub 112. In some embodiments, the catheter 110 includes a
catheter tube 116 distally extending from the distal end of the hub
112. In some embodiments, the catheter tube 116 may be configured
to slide over a guidewire 102. The catheter tube 116 includes a
proximal end 119 and a distal section 121 terminating in a distal
tip 118 and can define one or more catheter lumens 120 therein. In
some embodiments, the catheter 110 may include a Rapid Insertion
Central Catheter ("RICC"), such as described, for example, in U.S.
patent Ser. No. 10/376,675; U.S. application Ser. No. 17/031,478;
U.S. application Ser. No. 17/006,553; U.S. application Ser. No.
17/074,405; U.S. application Ser. No. 17/077,728; and U.S.
application Ser. No. 17/080,578, each of which is incorporated by
reference in its entirety into this application. As used herein,
the catheter insertion system 100 can be used to place a RICC to
access the vasculature of a patient. However, it will be
appreciated that embodiments disclosed herein can be used to place
various catheters, cannulas, single lumen catheters, multi-lumen
catheters, intravenous (IV) catheters, peripheral intravenous line
(PIV) catheters, peripherally inserted central catheters (PICC),
central venous catheter (CVC), dialysis catheters, drainage
catheters, and the like, without limitation.
[0047] Placing a catheter 110 requires dilating the tissue
surrounding an insertion site since typically the insertion site is
smaller than the diameter of the catheter 110. Current dilation
techniques use a hardened component that can cause tissue
deflection and excessive stretching of the skin tissue as the
hardened component is forced through the insertion site. The less
movement of the insertion site and the less tissue dilated around
the insertion site can lead to a more accurate placement of the
catheter 110 within the body and a better fit of the catheter 110
within the insertion site.
[0048] In some embodiments, a cross-sectional shape of the catheter
tube 116 may be cylindrical, a triangular prism, a rectangular
prism, or the like, although other cross-sectional shapes are also
contemplated. In some embodiments, the catheter tube 116 may be
configured to have a tapered junction 122 between the proximal end
119 of the catheter tube 116 and the distal section 121 of the
catheter tube 116. In some embodiments, the tapered junction 122
may be configured to include one or more dilation structures 123
extending from a side wall 124 of the tapered junction 122 that
will be described in more detail herein.
[0049] FIG. 2 illustrates a perspective view of components of a
catheter insertion system 100 including the tapered junction 122,
in accordance with some embodiments. In some embodiments, the
catheter tube 116 includes a proximal portion 125, the tapered
junction 122 having the side wall 124 and a distal portion 127
distal the tapered junction 122. In some embodiments, the catheter
tube 116 defines a central longitudinal axis 117. The proximal
portion 125 has a second diameter 126 and the distal portion 127
has a first diameter 128. In some embodiments, the second diameter
126 is larger than the first diameter 128. The tapered junction 122
is a portion of the catheter tube 116 that is tapered from the
proximal portion 125 to the distal portion 127 and from the second
diameter 126 to the first diameter 128. In some embodiments, the
tapered junction 122 may be evenly tapered, or unevenly tapered
from the proximal portion 125 to the distal portion 127. In some
embodiments, the first diameter 128 and the second diameter 126 may
be associated with the French catheter scale. In some embodiments,
the tapered junction 122 may be configured to include one or more
dilation structures 123 that may be configured to have a specific
shape to dilate the tissue surrounding an insertion site that will
be described in more detail herein.
[0050] FIG. 3A illustrates a schematic view of an exemplary
dilation structure, in accordance with some embodiments. In some
embodiments, the one or more dilation structures 123 may be
configured to include structures that extend from the tapered
junction 122 that dilate tissues upon insertion of the catheter 110
into an insertion site. In some embodiments, the one or more
dilation structures 123 include a protrusion 130 extending from the
side wall 124. In some embodiments, the one or more dilation
structures extend radially from the side wall 124 or longitudinally
from a proximal edge 135 to a distal edge 137. In some embodiments,
the protrusion 130 may be configured to extend from the side wall
124 to an apex 132. In some embodiments, the apex 132 defines the
furthest point of the protrusion 130 from the side wall 124. In
some embodiments, the protrusion 130 further defines a proximal
face 134, extending laterally between the apex 132 and the proximal
edge 135 and a distal face 136 extending between the apex 132 and
the distal edge 137. In some embodiments, the protrusion 130
includes a length 138 and a width 140. In some embodiments, as
illustrated in FIGS. 3C-3D, the length 138 may remain the same
while the apex 132 may be disposed anywhere along the length 138
including a longitudinal mid-point, towards and including the
proximal edge 135 or the distal edge 13
[0051] In some embodiments, the one or more dilation structures 123
may include one or more protrusions 130 or helices 160 that will be
described in more detail herein. FIGS. 3B-3I illustrate perspective
views of various embodiments of the protrusions 130 or helices 160,
in accordance with some embodiments. As will be appreciated, the
protrusions 130 can extend radially from the side wall 124. In some
embodiments, the one or more protrusions 130 can extend from the
side wall 124 at a same distance or at a different distance from
the side wall 124 of the tapered junction 122, as will be described
in more detail herein. In some embodiments, as illustrated in FIGS.
3B-3C, the protrusion 130 can include various geometries. For
example, as illustrated in FIG. 3B, the proximal face 134A or
distal face 136A can define a cutting edge extending longitudinally
through a midline 139 of the proximal face 134A or the distal face
136A. In some embodiments, the cutting edge may be configured to
assist the user with dilating the tissue around the insertion site
and avoid tissue deflection. As illustrated in FIG. 3D, the tapered
junction 122 can include a plurality of protrusions 130A-C,
defining the longitudinally rounded distal face 136, the midline
139 and the longitudinally rounded proximal face 134. An apex 132A
of a first protrusion 130A can be longitudinally offset from an
apex 132B of a second protrusion 130B.
[0052] FIG. 3E illustrates a perspective view of the one or more
protrusions 130 wherein the one or more protrusions 130 include a
plurality of ribs 150, wherein the plurality of ribs 150 are
repeated rounded protrusions. In some embodiments, each rib of the
plurality of ribs 150 includes a rib face 155 extending from a
proximal edge 156 to a distal edge 157, a rib length 158 extending
from the proximal edge 156 to the distal edge 157, and a rib width
159. In some embodiments, the rib face 155 defines the rounded
outer profile of the protrusion 130. In some embodiments, the rib
length 158 of the plurality of ribs 150 may be the same or varied.
In some embodiments, the rib width 159 of the plurality of ribs 150
may be the same or varied. In an embodiment, the rib width 159
tapers from a larger rib width 159 proximally to a smaller rib
width 159 distally.
[0053] In some embodiments, the plurality of ribs 150 may be
randomly distributed or evenly distributed on the side wall 124 of
the tapered junction 122. In some embodiments, the plurality of
ribs 150 may be longitudinally organized into a first line 152 of
two or more ribs and a second line 154 of two or more ribs. In an
embodiment, each rib in the first line 152 may be longitudinally
aligned with each rib in the second line 154. In an embodiment as
illustrated in FIG. 3E, each rib in the first line 152 may be
longitudinally offset from each rib in the second line 154. Each
rib in the first line 152 may be evenly spaced or unevenly spaced
from the other ribs in the first line 152 and each rib in the
second line may be evenly spaced or unevenly spaced from the other
ribs in the second line. The first line 152 and the second line 154
can be disposed on opposite sides of the tapered junction 122. In
some embodiments, the first line 152 may be aligned along a lateral
side and the second line 154 may be aligned along a transverse
side, or at an angle therebetween.
[0054] In an embodiment, the first line of ribs 152 can be arranged
in a helical pattern about the longitudinal axis 117, where each
rib of the first line of ribs 152 are rotationally offset by an
angle about the longitudinal axis 117 and longitudinally offset by
a distance. In an embodiment, each rib of the first line of ribs
152 can be rotationally offset by the same angle or by different
angles. In an embodiment, each rib of the first line of ribs 152
can be longitudinally offset by the same distance or different
distances.
[0055] FIGS. 3F-3I illustrates a perspective view of the one or
more dilation structures 123 wherein the dilation structure 123
includes the helix 160 extending radially about longitudinal axis
117 from the side wall 124. In some embodiments, the helix 160 may
be a right handed helix or a left handed helix. In some
embodiments, as illustrated in FIG. 3F, the helix 160 may have a
longitudinal length 161. In some embodiments, e.g. FIG. 3F, the
dilation structure 123 can include a relatively high number of
revolutions per longitudinal length 161, providing a relatively
"tighter" helical structure. In some embodiments, e.g. FIG. 3G, the
dilation structure 123 can include a relatively low number of
revolutions per longitudinal length 161, providing a relatively
"looser" helical structure.
[0056] In some embodiments, each revolution of the helix 160 may
extend radially the same distance from the side wall 124, as
illustrated in FIG. 3G, or each revolution may extend different
distances from the side wall 124. For example, as illustrated in
FIG. 3H, the helix 160 may extend a greater distance from the side
wall 124 at a proximal end and may extend a lesser distance from
the side wall 124 at a distal end. Advantageously, by rotating the
tapered junction 122, including the helical dilation structure 123,
the mechanical action of the helix 160 pulls the tapered junction
122 through the insertion site 104, avoiding tissue deflection or
distortion. In some embodiments, as illustrated in FIG. 3I, the
helix 160 may be configured to have beveled, chamfered, squared or
rounded edges. The beveled or chamfered edges may be configured to
partially cut or fully cut the tissue surrounding the insertion
site 104 as the helix 160 is rotated, further dilating the tissue.
Although FIGS. 3A-3I illustrate various embodiments of the one or
more dilation structures 123 of the tapered junction 122, other
shapes or protrusions are considered.
[0057] FIGS. 4A-4D illustrate cross sections of the one or more
dilation structures 123 including the one or more protrusions 130
of the tapered junction 122, in accordance with some embodiments.
In some embodiments, the catheter tube 116 includes the one or more
lumens 120 extending therethrough. In some embodiments, the
protrusions 130 include a height 141. As used herein, the "height"
of the protrusion 130 is a distance of an outer most point of the
protrusion 130 extending radially from the side wall 124. In some
embodiments, the protrusion 130 defines a width 140. As used herein
a "width" is a distance extending parallel to the side wall 124. In
some embodiments, the protrusions 130 may have the same width 140
and the same height 141 or different widths 140 and different
heights 141.
[0058] As illustrated in FIG. 4A, the tapered junction 122 may
include four protrusions 130A-D extending radially from the side
wall 124 of the tapered junction 122. In some embodiments, a first
ridge 130A may be equidistant from a second ridge 130B and a fourth
ridge 130D. In some embodiments, the fourth ridge 130D may be
equidistant from the first ridge 130A and a third ridge 130C.
Simply put, the four protrusions 130A-D may be evenly spaced
radially around the tapered junction 122. As illustrated in FIG.
4B, in some embodiments, the tapered junction 122 may include eight
ridges 130A-H extending from the side wall 124 of the tapered
junction 122. In some embodiments, the eight ridges 132A-H may be
even spaced, unevenly spaced or clustered together around the
tapered junction 122. Although eight ridges are illustrated,
greater or lesser number of ridges are also contemplated.
[0059] As illustrated in FIG. 4C, in some embodiments, the tapered
junction 122 may include two protrusions 130A, 130B extending from
the side wall 124 of the catheter tube 116. In some embodiments,
the first protrusion 130A and the second protrusion 130B define a
lateral axis 129. In some embodiments, the first protrusion 130A
may be longitudinally aligned with the second protrusion 130B,
defining a lateral axis 129 on opposite sides of the tapered
junction 122. In some embodiments, the first protrusion 130A may be
longitudinally offset from the second protrusion 130B. In some
embodiments, the one or more protrusions 130 may include the
plurality of ribs 150. In some embodiments, the plurality of ribs
150 may be organized in the first line 152 and the second line 154.
As illustrated in FIG. 4D, in some embodiments, the first line 152
may longitudinally aligned with the second line 154, on opposite
sides of the catheter tube 116. In some embodiments, the first line
152 may be longitudinally offset from the second line 154. In some
embodiments, the plurality of ribs 150 may radially extend evenly
or unevenly from the side wall 124 to define different distances
from the side wall 124 of the tapered junction 122. In some
embodiments, the plurality of ribs 150 located proximally may
radially extend a greater distance from the side wall 124 than the
ribs located distally. In some embodiments, the plurality of ribs
150 may be organized into a plurality of lines, evenly spaced
around the tapered junction 122. In some embodiments, the plurality
of ribs 150 may be spaced in an organized configuration or a random
configuration around the catheter tube 116. In some embodiments the
plurality of ribs may be arranged in a helical line about the
longitudinal axis 117.
[0060] FIGS. 5A-5C illustrate an exemplary method of using
inserting a catheter 110 into an insertion site 104. In some
embodiments, the catheter insertion system 100 includes a guidewire
102. As illustrated in FIG. 5A, the guidewire 102 may be inserted
into an insertion site 104 in a target area 106. In some
embodiments, the target area 106 may include a target vessel. In
some embodiments, a user may confirm the guidewire 102 is in the
correct target location. In some embodiments, as illustrated in
FIG. 5B, the catheter insertion system 100 further includes the
catheter 110 having the hub 112 disposed at a proximal end and
including one or more extension legs extending proximally from the
proximal end of the hub 112. The catheter 110 includes the catheter
tube 116 distally extending from the distal end of the hub 112. The
catheter tube 116 may be configured to slide over the guidewire
102. The catheter tube 116 includes the proximal end 119 and a
distal section 121, terminating in the distal tip 118 and can
define the one or more catheter lumens 120 therein. The catheter
tube 116 further includes the proximal portion 125, the tapered
junction 122 having the side wall 124 and the distal portion 127.
The proximal portion 125 has the second diameter 126 and the distal
portion 127 has the first diameter 128 with the second diameter 126
being larger than the first diameter 128. The tapered junction 122
may be configured to include one or more dilation structures 123
radially extending from the side wall 124 and configured to have a
specific shape to dilate the tissue surrounding the skin insertion
site 104 while mitigating tissue deflection. The dilation
structures 123 can include one or more protrusions 130 or helices
160.
[0061] Once the guidewire 102 is placed at the correct target
location, the catheter 110 may be slid over the guidewire 102 and
urged into the skin insertion site 104 as illustrated in FIG. 5B.
Since the distal portion 127 defines a smaller first diameter 128,
the distal portion 127 can enter the skin insertion site 104 more
easily. The tapered junction 122 including the one or more dilation
structures 123 can then dilate the skin insertion site 104 for the
larger second diameter 126 and the proximal portion 125. As the
catheter 110 is urged into the skin insertion site 104, the one or
more dilation structures 123 facilitates dilating the tissue around
the skin insertion site 104 by stretching the tissue around the
skin insertion site 104 along a lateral axis. For example, a
rotating helix 160 may be configured to use mechanical advantage to
pull the tapered junction 122 through the skin insertion site 104,
minimizing tissue deflection. In some embodiments, the user may
further twist the catheter 110 clockwise or counterclockwise about
the longitudinal axis 117 while urging the catheter 110 into the
skin insertion site 104 to further dilate the tissue surrounding
the insertion site 104.
[0062] In some embodiments, the user may "wiggle" the catheter 110
back and forth along the lateral axis, transverse axis or a
combination thereof, while urging the catheter 110 into the
insertion site 104 to further dilate the tissue surrounding the
insertion site 104. In some embodiments, e.g. FIG. 3D, the user may
wiggle the catheter 110 back and forth along the lateral or a
transverse axis. In some embodiments, e.g. FIGS. 3E-3I, the user
may wiggle and twist the catheter 110 while urging the catheter 110
into the insertion site 104. In some embodiments, the user may
continue to wiggle or twist the catheter 110 until the catheter 110
is completely inserted into the insertion site 104, as illustrated
in FIG. 5C. Once the catheter 110 is fully inserted, the user may
confirm proper target location placement of the catheter 110
through imaging. In some embodiments, using the catheter 110 to
dilate the insertion site 104 leads to an increased fit of the
catheter 110 into the insertion site 104, while minimizing tissue
deflection around the insertion site 104.
[0063] FIG. 6 illustrates a flow chart of an exemplary method 300
of inserting a catheter 110 into an insertion site 104 using a
catheter insertion system 100, in accordance with some embodiments.
In some embodiments, the method 300 includes inserting a distal
section 121 of the catheter 110 into the insertion site 104 (block
302). In some embodiments, the distal section 121 includes the
tapered junction 122 having one or more dilation structures 123
radially extending from the side wall 124 and a distal portion 127
extending from the distal end of the tapered junction, having the
first diameter 128.
[0064] The method 300 includes dilating the skin insertion site
104(block 304). In some embodiments, dilating the insertion site
104 includes dilating from the smaller first diameter 128 to the
larger second diameter 126. In some embodiments, dilating the skin
insertion site 104 includes urging the tapered junction 122 of the
catheter 110 into the skin insertion site 104, the tapered junction
122 includes the one or more dilation structures 123 radially
extending from the side wall 124. In some embodiments, the one or
more dilation structures 123 include the one or more protrusions
130 or the helix 160. In some embodiments, dilating the insertion
site 104 includes twisting the catheter 110 clockwise or
counterclockwise around the central longitudinal axis 117. In some
embodiments, dilating the insertion site 104 includes wiggling the
catheter 110 along the transverse or lateral axis.
[0065] The method 300 further includes advancing the proximal
portion 125 of the catheter 110 into the insertion site 104. In
some embodiments, the proximal portion 125 includes the second
diameter 126. In some embodiments, the second diameter 126 is
greater than the first diameter 128.
[0066] While some particular embodiments have been disclosed
herein, and while the particular embodiments have been disclosed in
some detail, it is not the intention for the particular embodiments
to limit the scope of the concepts provided herein. Additional
adaptations and/or modifications can appear to those of ordinary
skill in the art, and, in broader aspects, these adaptations and/or
modifications are encompassed as well. Accordingly, departures may
be made from the particular embodiments disclosed herein without
departing from the scope of the concepts provided herein.
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